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临床试验/NCT05638386
NCT05638386已完成不适用

Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery

Reinier Haga Orthopedisch Centrum1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
384
试验地点
1
主要终点
Number of patients with postoperative bleeding

研究概览

简要总结

Introduction: Complications of robotic-assisted total knee arthroplasty (TKA) seem to be rare and consist mainly of infections or fractures. In the Reinier Haga Orthopedisch Centrum (RHOC), postoperative bleeding is experienced to be a complication that often occurs, mainly at the tibial wounds of the registration pins used in robotic-assisted TKA. This often results in longer hospital stay and might interfere with the current fast track knee surgery by a delayed discharge. To overcome this complication, nowadays bone plugs are used in the two drill-holes. Currently, it is unknown whether these bone plugs reduces the incidence of postoperative bleeding.

Objective: To evaluate the incidence of postoperative bleeding in patients that underwent a robotic-assisted TKA and received bone plugs in the two drill-holes in the tibia, compared to patients that underwent the same operation but did not receive bone plugs.

Study design: Retrospective, inventory study

Study population: All patients that underwent a robotic-assisted TKA in the RHOC from December 2020 till October 2022.

Intervention: In the past, some patients that underwent a robotic-assisted TKA received a bone plug in the two tibial drill-holes. This bone is collected from the excess bone that is removed during the operation.

Main study parameters/endpoints: Incidence of postoperative bleeding in both groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Underwent robotic-assisted total knee arthroplasty between December 2020 and October 2022 with or without the use of bone plugs
  • •Does not object against use of medical data

排除标准

  • 未提供

结局指标

主要结局

Number of patients with postoperative bleeding

时间窗: December 2020 - October 2022

次要结局

  • Length of hospital stay(December 2020 - October 2022)
  • Complications(December 2020 - October 2022)
  • Reasons which might lengthen hospital stay(December 2020 - October 2022)

研究者

发起方
Reinier Haga Orthopedisch Centrum
申办方类型
Other
责任方
Sponsor

研究点 (1)

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